Funding: UK Medical Research Council (MRC); International Partnership of Microbicides (IPM); European and Developing Countries Clinical Trials Partnership (EDCTP)

Field laboratory

Summary: Intravaginal practices (IVP) are common in sub-Saharan Africa and have been shown to be associated with HIV in some cross-sectional studies. Three prospective studies investigating these behaviours in Africa have shown conflicting results. A recent meta-analysis shows a high level of heterogeneity between individual study results. More prospective data are needed to understand this common practice, which may be a risk factor for HIV, yet is potentially modifiable. The IVP Project was nested within another EDCTP-funded study - Site Preparation and Capacity Strengthening for Trials of Vaginal Microbicides in Tanzania and Uganda (Women’s Health Project). the overall objectives of the IVP Project are to describe and quantify the types of IVP in the study populations, investigate associations between IVP and sexually transmitted infections (STIs), including HIV, and to investigate the biological basis for the epidemiological associations. Three research projects have been carried out to meet these objectives:

Laboratory specimen storage in the field

A nested epidemiological study within the main study in Tanzania and Uganda, measuring IVP prevalence and the associations between IVP, cervicovaginal infections (including STIs) and HIV infection.

The “Diary Study” - A qualitative sub-study of 100 women who were randomly selected from women enrolled in the main study in Tanzanian and Uganda. Consenting participants were asked to complete a daily, pictorial vaginal practice diary for six weeks. In-depth interviews and focus group discussions were also conducted to explore the nature and sociocultural context of IVP in more detail.

The “Inflammation Study” - A biomedical sub-study of 100 women from the main study in Tanzania who were selected based on their reported IVP behaviours in the main cohort enrollment questionnaire, with over-sampling of behaviours assumed to carry higher risk (e.g. use of clothes or insertion of herbs). Consenting participants were followed up three times per week for four weeks to investigate short-term variations in local vaginal immunity and ecology and their association with different IVP behaviours. Colposcopic examination was carried out at the first and last visits, and associations between IVP, colposcopic findings, vaginal flora and inflammatory biomarkers are being examined.